Abstract
A Clinical Endpoint Committee (CEC) is a panel of unbiased, third-party experts charged with centrally reviewing and classifying suspected endpoints, ascertaining whether they meet protocol definitions and providing standardized endpoint outcomes for the purposes of statistical analysis. CECs review and adjudicate endpoint-specific data, applying complex medical definitions to determine these outcomes. The use of CECs to adjudicate suspected endpoints has increased considerably over the past 10 years. CEC-adjudicated endpoint outcomes can figure prominently in a number of key clinical trial decision-making processes: power calculations, periodic safety reviews by Data Safety Monitoring Boards (DSMB), sample size reestimation and other interim analyses, next stage progress for adaptive design trials, study completion for event-driven trials and overall results for efficacy and safety analyses. Information reviewed by the CEC for each endpoint is primarily based on source documentation from the patient chart, lab reports, radiology reports, consultation notes, medical imaging data, data from external devices and autopsy reports. It is through review of this kind of descriptive chart documentation that CEC adjudicators are able to independently and critically assess the circumstances surrounding the suspected endpoint, so that they can produce a medically precise adjudicated outcome. Use of online adjudication technology enables implementation of an end-to-end, transparent endpoint workflow, which creates significant cost efficiencies and measurably reduces cycle times by offering a collaborative workspace for all relevant stakeholders to contribute to the endpoint process, by partially automating the process steps with a flexible electronic workflow and by integrating all components of the endpoint management and adjudication work flows into a single, seamless system, which is imbedded within an EDC platform.
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